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Central Nervous System Depressant

Low Sodium Oxybate for Idiopathic Hypersomnia

Phase 4

Recruiting

Led By Chad Ruoff, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects aged 18 - 65 years

If treated with wake promoting agents, traditional stimulants and/or antidepressant(s), a stable dose and regimen will be required for at least 2 months before study entry and throughout the main study

Must not have

Renal or hepatic impairment

Heart failure, severe hypertension or other cardiovascular disease compromising the patient's well-being or ability to participate in this study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will study how low sodium oxybate impacts sleep quality & duration in people with idiopathic hypersomnia using new tools to monitor sleep.

Who is the study for?

This trial is for adults aged 18-65 with idiopathic hypersomnia, who often sleep over 10 hours daily including naps. They must be recommended low sodium oxybate by a sleep specialist and agree to use contraception. Exclusions include certain medical conditions like seizure disorders, recent drug abuse, or severe cardiovascular issues.

What is being tested?

Researchers are testing the effects of low sodium oxybate on people with idiopathic hypersomnia using novel monitoring tools like polysomnography, EEG earbuds, and an Axivity device to track sleep patterns and wakefulness.

What are the potential side effects?

While not explicitly listed in the provided information, common side effects of low sodium oxybate may include dizziness, nausea, headache, confusion, bedwetting and less commonly breathing problems or mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have been on a stable dose of medication for sleep or mood for at least 2 months.

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I have been diagnosed with Idiopathic Hypersomnia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have kidney or liver problems.

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I do not have severe heart or blood pressure problems that would stop me from joining this study.

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I am receiving treatment for sleep apnea.

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I have a lung condition like COPD, asthma, or pulmonary hypertension.

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I have been diagnosed with a severe sleep breathing disorder.

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I cannot or will not remove my ear jewelry/piercings.

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I have a history of brain-related conditions, like seizures or severe head injuries.

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I have a rare genetic disorder affecting my metabolism.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Total Sleep Time

Secondary study objectives

Change in total sleep time as measured by Axivity device

Change in total sleep time as measured by Nextsense EEG earbuds

Change in total sleep time as measured by patient sleep diary

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Low Soduim Oxybate for Idiopathic HypersomniaExperimental Treatment4 Interventions

Subjects prescribed with low sodium oxybate for idopathic hypersomnia will have a 24-hour polysomnography, wear an Axivity wristband and Nextsense EEG earbuds to evaluate total sleep time.

0 / 11Eligibility criteria met